Nausea, vomiting, loss of appetite, constipation, bad taste in your mouth, dry mouth, mouth sores, dizziness, headache, or trouble sleeping may occur. Rarely, nausea and vomiting can be severe. Taking this medication at bedtime may help reduce nausea. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen nausea and vomiting. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Rarely, this medication may also cause certain cancers of the bone marrow or blood cells. Your doctor will monitor your blood cell count. Tell your doctor right away if you develop any of the following symptoms:

This medication may raise your blood pressure and heart rate. Sometimes these effects can be serious. Check your blood pressure and heart rate regularly and tell your doctor if the results are high. Your doctor may control your blood pressure and heart rate with medication.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

rash

itching/swelling (especially of the face/tongue/throat)

severe dizziness

trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking niraparib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Niraparib can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Your doctor may order a pregnancy test before you start this medication. Discuss reliable forms of birth control (such as condoms, birth control pills) with your doctor, for use during treatment and for 6 months after the last dose of niraparib. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended during treatment and for 1 month after the last dose. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Lab and/or medical tests (such as complete blood count, blood pressure, heart rate) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised October 2018.

Copyright(c) 2018 First Databank, Inc.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.